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临床试验/NCT06117098
NCT06117098招募中不适用

Stepping Stones for Successful Evaluation of Mobile App Efficacy for Risk Reduction of Type 2 Diabetes

Oslo Metropolitan University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年5月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Resources

研究概览

简要总结

The aim of this feasibility study is to investigate whether a full scale RCT on the efficacy of a mobile app for risk reduction on type 2 diabetes can be conducted in the way it is planned or whether it needs to be modified. This will be investigated through a feasibility study (small scale RCT) on the efficacy of mobile technology on risk reduction of type 2 diabetes.

详细描述

A small scale RCT will be carried out a the collaborating Healthy Life Centres (HLC). Trained health personnel will deliver the lifestyle programs at these centres, and the content of their programs should be in line with the national guidelines for physical activity and nutrition. The study sample 60 participants with high risk of developing diabetes type 2.

The participants will be randomized into three study arms, 20 participants in each. One group, the intervention group, will receive the mobile app, the second group will receive group-based lifestyle intervention at the HLCs and the third group will receive group based lifestyle intervention at the HLCs and a mobile application. The middle arm will serve as the control arm for both the non-inferiority trial ( mobile application group and HLC lifestyle intervention only) and for the superiority trial (HLC lifestyle intervention plus mobile app and HLC intervention only).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •smart phone
  • •prediabetes

排除标准

  • •not interested in lifestyle change

研究组 & 干预措施

Mobile application

Experimental

This group will receive individual guidance via the mobile application (12 weeks)

干预措施: Mobile application (Device)

Group-based lifestyle intervention at the Healthy Lifestyle Centres

Active Comparator

This group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre (12 weeks)

干预措施: Group-based lifestyle intervention (Behavioral)

Group-based lifestyle intervention at a Healthy Lifestyle Centre and recieving a mobile application

Experimental

This group will receive a group-based lifestyle intervention program at a Healthy Lifestyle Centre plus the mobile application (12 weeks)

干预措施: Group-based lifestyle intervention at a Healthy Lifestyle Centre + mobile application" (Behavioral)

结局指标

主要结局

Resources

时间窗: Nine months

We will assess the randomization procedure and asses time spent on the first consultation with the participants. Throughout the study period, the supervisor will log all time spent monitoring participants and giving individual feedback through the app.

Management

时间窗: Nine months

The use of the app will be registered in terms of actual use and if patients answered tasks within a week, all based on data shown in the administrator interface. Data on adherence to provided tasks and problems experienced with the mobile app will be retrieved from the app-database. We will also assess whether there are any problems with data management involved in the study and assess whether the study personnel had any challenges in conduct of the study.

Recruitment rate

时间窗: Six months

We want to assess the proportion of participants willing and able to take part in the study after referral from general practitioner in two different regions in East Norway. Information will be recorded continuously after telephone contact.

Satisfaction with the app

时间窗: Three months

User satisfaction with the application will be assessed with the System Usability Scale. (SUS), a paper questionnaire at the end of the intervention.The SUS is a technology independent, 10-item questionnaire with a score between 0 and 100 were 0 represents low usability and 100 represent high usability. We will also asses the experienced usefulness of the app after 12 weeks. This will be measured through a questionnaire designed for this study consisting of 16 questions; 13 questions with answers on a Likert scale (0 to 100), 3 multiple-choice questions, and 1 open-ended question.

Change and ceiling and floor effect in outcomes

时间窗: Three months

These outcomes will be determined by evaluating whether changes in quality of life and physical activity over a 12-week period could be observed and whether these outcomes disclose ceiling or floor effects. To assess these domains, we will use part of standard questionnaires being used in Healthy Life Centers at the beginning and ending of a 12-week intervention period, being the COOP/WONCA (the Dartmount COOP/World Organization of Family Doctors functional health assessment). This is a questionnaire assessing changes in quality of life.It consists of six questions across six domains with a score of 1 in each domain representing the best possible score while a score of 5 is the worst possible score. Physical activity will be assessed with the validated International Physical Activity Questionnaire (IPAQ) short form. It consists of eight items and encompasses questions regarding time spent walking, in moderate and vigorous intensity physical activity, besides sitting time.

次要结局

  • Antropometric measures(Three months)

研究者

发起方
Oslo Metropolitan University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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